{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-regulations-2026/regulation-9",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-regulations-2026/regulation-9.json",
  "legislation": "ukdsi/2026/9780348278958",
  "legislation_title": "The Human Medicines (Amendment) Regulations 2026",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-amendment-regulations-2026",
  "path": "regulation/9",
  "kind": "regulation",
  "number": "9",
  "heading": "Insertion of new regulation 235A",
  "text": "After regulation 235 (exemption for sale, supply or administration by certain persons), insert—\n“Exemption for supply or administration of certain medicines used for vaccination\n235A (1) Regulations 214, 220 and 221 do not apply to the supply or administration of a medicinal product used for vaccination in accordance with conditions A to F by—\n(a) a public health agency;\n(b) a health authority or special health authority;\n(c) an NHS Trust;\n(d) an NHS Foundation Trust;\n(e) a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006); or\n(f) a person under relevant arrangements.\n(2) Condition A is that the medicinal product is used for vaccination—\n(a) for the purpose of providing protection against an infectious disease; and\n(b) as part of a vaccination programme that has been approved by the Secretary of State, the Scottish Ministers, the Welsh Ministers or the Minister of Health in Northern Ireland.\n(3) Condition B is that the medicinal product is supplied for the purpose of being administered to a person in accordance with the requirements of a vaccine group direction which has been produced by a public health agency.\n(4) Condition C is that the vaccine group direction—\n(a) is signed by or on behalf of—\n(i) in the case of supply or administration by a body listed in paragraph (1)(a) to (e), a senior manager of that body, or\n(ii) in the case of supply or administration by a person as mentioned in paragraph (1)(f), a senior manager of the body that enters into the relevant arrangements with that person; and\n(b) has effect at the time at which the medicinal product is administered.\n(5) Condition D is that the individual who administers the medicinal product is either at the same location and under the supervision of an individual who, or is an individual who—\n(a) has—\n(i) assessed and determined that the person who is to receive the medicinal product is eligible for the treatment, and\n(ii) obtained and recorded the informed consent of, or in respect of, the person who is to receive the medicinal product; and\n(b) belongs to one of the classes of individuals specified in Part 4 of Schedule 16.\n(6) Condition E is that the vaccine group direction contains the particulars specified in Part 1 of Schedule 16, and specifies—\n(a) the classes of persons permitted to administer medicinal products under the direction;\n(b) the process by which a person of a specified class is designated, and by whom, as a person permitted to administer medicinal products under the direction; and\n(c) requirements, where appropriate, for the supervision of a person who, on any particular occasion, administers a medicinal product under the direction.\n(7) Condition F is that, when the medicinal product is administered, there is in force in relation to it—\n(a) a UK marketing authorisation; or\n(b) an authorisation by the licensing authority on a temporary basis under regulation 174.\n(8) In this regulation—\n“a public health agency” means—\n(a) Public Health Scotland in respect of Scotland;\n(b) Public Health Wales in respect of Wales;\n(c) the UK Health Security Agency in respect of England;\n(d) the Public Health Agency in respect of Northern Ireland;\n“relevant arrangements” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence);\n“senior manager” means a person who plays a significant role (irrespective of whether other individuals also do so) in—\n(a) the making of decisions about how the whole or a substantial part of the activities of the body in question are to be managed or organised, or\n(b) the actual managing or organising of the whole or a substantial part of those activities.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2026/9780348278958/regulation/9",
    "retrieved_at": "2026-10-30T14:37:58.296902+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}